Critical IllnessNCT07901140
Adverse Events During Physical Therapy in Neurocritical ICU Patients
An observational study of Critical Illness and Brain Injury, run by Hospital H+ Queretaro at 2 sites in Mexico.
Trial summary
The goal of this observational study is to identify the clinical, neurological, hemodynamic, and respiratory variables associated with the occurrence of adverse events during physical therapy interventions in adult neurocritical patients admitted to the Intensive Care Unit (ICU). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Brain Injury, Stroke
- What is being tested?
- Physical Therapy Intervention
- How many people
- 47 participants
- Where
- 2 sitesMexico
- Study dates
- 23 Sep 2026to 31 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Medical records of adult neurocritical patients admitted to the Intensive Care Unit (ICU) at a tertiary hospital in Querétaro, Mexico, who received physical therapy interventions between October 2023 and April 2026.
Who may be able to join
- Adult patients (18 years or older) admitted to the Intensive Care Unit (ICU).
- Patients classified with a neurocritical condition (e.g., ischemic or hemorrhagic stroke, brain tumor, aneurysm, traumatic brain injury, subarachnoid hemorrhage).
- Complete medical records including documentation, notes, and charts from medical, nursing, and physical therapy departments.
- Documented physical therapy intervention, vital signs monitoring, neurological scale scores, and pharmacological dosage records.
Who cannot join
- Medical records of adult patients admitted to general hospital wards or the emergency department.
- Medical records of patients admitted to the Neonatal Intensive Care Unit (NICU).
- Medical records of pregnant patients.
- Medical records of patients not classified as neurocritical
- Medical records of terminal patients or patients receiving palliative care with an estimated life expectancy of less than 24 hours at the time of ICU admission.
- Medical records lacking documentation of physical therapy interventions.
- Medical records lacking documentation of required hemodynamic and neurological values for risk analysis.
- Medical records where collected data does not allow determining the presence or absence of adverse events during physical therapy.
Trial locations and contacts
2 sites in 1 country.
Mexico2 sites
Hospital H+ Querétaro, Santiago de Querétaro, Querétaro
Querétaro
Hospital H+ Querétaro, Santiago de Querétaro, Querétaro
Querétaro City, Querétaro
About this study
Official title: Clinicopathological Analysis of Factors Associated With the Development of Adverse Events During Physical Therapy Intervention in Neurocritical Patients in the Intensive Care Unit
The goal of this observational study is to identify the clinical, neurological, hemodynamic, and respiratory variables associated with the occurrence of adverse events during physical therapy interventions in adult neurocritical patients admitted to the Intensive Care Unit (ICU).
The main questions it aims to answer are:
What clinical, neurological, hemodynamic, and respiratory factors are associated with adverse events during physical therapy in neurocritical patients? What is the incidence and type of adverse events that occur most frequently during physical therapy in this patient population? Researchers will compare clinical and physiological data between patients who experienced adverse events during physical therapy and those who did not, to determine risk factors associated with these complications. Participants' data will be retrospectively collected from medical records without performing new clinical interventions.
- Conditions
- Critical Illness, Brain Injury, Stroke, Subarachnoid Hemorrhage, Brain Neoplasms, Orthostatic Intolerance
- Being tested
- Physical Therapy Intervention
- Keywords
- Early Mobilization, Neurocritical Care, Physical Therapy, Intensive Care Unit, Hemodynamic Stability
- Medical subject headings
- Critical Illness, Brain Injuries, Stroke, Subarachnoid Hemorrhage, Brain Neoplasms, Orthostatic Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Therapy InterventionOther
Physical therapy and mobilization procedures administered to neurocritical patients during their ICU stay as recorded in medical, nursing, and physical therapy notes. Retrospective data collection evaluates baseline clinical-pathological risk profile and monitoring parameters (hemodynamics, neurological, respiratory).
| Study group | Role | What they receive |
|---|---|---|
| Adverse Event Group | Adult neurocritical ICU patients who presented at least one adverse event (e.g., hypotension, hypertension, tachycardia, bradycardia, oxygen desaturation, increased ICP, decreased CPP, acute neurological deterioration) during the physical therapy intervention. Receives: Other: Physical Therapy Intervention | |
| No Adverse Event Group | Adult neurocritical ICU patients who underwent physical therapy intervention without experiencing any adverse events during the session. Receives: Other: Physical Therapy Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events During Physical Therapy
Presence or absence of any adverse event (binary variable: Yes/No) occurring during or immediately following a physical therapy session in adult neurocritical ICU patients. Adverse events include: hypotension (drop in SBP > 20 mmHg), hypertension, tachycardia, bradycardia, oxygen desaturation, acute neurological deterioration, increase in intracranial pressure (ICP), or decrease in cerebral perfusion pressure (CPP) requiring therapy session suspension.
Measured: During the physical therapy session (from initiation up to immediate post-session evaluation, up to 1 hour per session).
Secondary outcomes (3)
Clinical and Physiological Predictors of Adverse Events
Association between baseline clinical-pathological variables and the occurrence of adverse events during physical therapy. Evaluated parameters include: Glasgow Coma Scale (GCS), Mean Arterial Pressure (MAP), Richmond Agitation-Sedation Scale (RASS), vasopressor dependence, SpO2/FiO2 ratio (SAFI), external ventricular drain presence, and decompressive procedure history.
Measured: Baseline assessment immediately prior to each physical therapy session.
Frequency and Specific Types of Adverse Events
Distribution and frequency of specific types of adverse events recorded during therapy sessions, categorized into hemodynamic (hypotension, hypertension, tachycardia, bradycardia), respiratory (oxygen desaturation), and neurological (acute deterioration, ICP increase, CPP decrease).
Measured: During each physical therapy session throughout the ICU stay (retrospectively evaluated from October 2023 to April 2026).
Comparative Analysis of Hemodynamic versus Respiratory Variables
Statistical comparison using Student's t-test to evaluate whether hemodynamic variables show significantly higher association with adverse events compared to respiratory variables.
Measured: Retrospective evaluation spanning the total ICU stay for each patient record (October 2023 to April 2026).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study start23 Sep 2026
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 47 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital H+ Queretaro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose J Zaragoza, MD MSc, Hospital H+ Queretaro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07901140
- Sponsor's protocol ID
- CEI2026-22/06/V1
- Status last verified
- Oct 2026
- First submitted
- 21 Oct 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinicopathological Analysis of Factors Associated With the Development of Adverse Events During Physical Therapy Intervention in Neurocritical Patients in the Intensive Care Unit
- ClinicalTrials.gov ID
- NCT07901140
- Acronym / sponsor ID
- CEI2026-22/06/V1
- Conditions
- Critical Illness, Brain Injury, Stroke, Subarachnoid Hemorrhage, Brain Neoplasms, Orthostatic Intolerance
- Keywords
- Early Mobilization, Neurocritical Care, Physical Therapy, Intensive Care Unit, Hemodynamic Stability
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 47 participants (estimated)
- Lead sponsor
- Hospital H+ QueretaroUniversity, hospital or other
- Study start
- 23 Sep 2026 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 28 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to identify the clinical, neurological, hemodynamic, and respiratory variables associated with the occurrence of adverse events during physical therapy interventions in adult neurocritical patients admitted to the Intensive Care Unit (ICU).
The main questions it aims to answer are:
What clinical, neurological, hemodynamic, and respiratory factors are associated with adverse events during physical therapy in neurocritical patients? What is the incidence and type of adverse events that occur most frequently during physical therapy in this patient population? Researchers will compare clinical and physiological data between patients who experienced adverse events during physical therapy and those who did not, to determine risk factors associated with these complications. Participants' data will be retrospectively collected from medical records without performing new clinical interventions.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adverse Event Group | – | Other: Physical Therapy InterventionAdult neurocritical ICU patients who presented at least one adverse event (e.g., hypotension, hypertension, tachycardia, bradycardia, oxygen desaturation, increased ICP, decreased CPP, acute neurological deterioration) during the physical therapy intervention. |
| No Adverse Event Group | – | Other: Physical Therapy InterventionAdult neurocritical ICU patients who underwent physical therapy intervention without experiencing any adverse events during the session. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Medical records of adult neurocritical patients admitted to the Intensive Care Unit (ICU) at a tertiary hospital in Querétaro, Mexico, who received physical therapy interventions between October 2023 and April 2026.
Key inclusion criteria (4 listed)
- Adult patients (18 years or older) admitted to the Intensive Care Unit (ICU).
- Patients classified with a neurocritical condition (e.g., ischemic or hemorrhagic stroke, brain tumor, aneurysm, traumatic brain injury, subarachnoid hemorrhage).
- Complete medical records including documentation, notes, and charts from medical, nursing, and physical therapy departments.
- Documented physical therapy intervention, vital signs monitoring, neurological scale scores, and pharmacological dosage records.
Key exclusion criteria (8 listed)
- Medical records of adult patients admitted to general hospital wards or the emergency department.
- Medical records of patients admitted to the Neonatal Intensive Care Unit (NICU).
- Medical records of pregnant patients.
- Medical records of patients not classified as neurocritical
- Medical records of terminal patients or patients receiving palliative care with an estimated life expectancy of less than 24 hours at the time of ICU admission.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical Therapy InterventionPhysical therapy and mobilization procedures administered to neurocritical patients during their ICU stay as recorded in medical, nursing, and physical therapy notes. Retrospective data collection evaluates baseline clinical-pathological risk profile and monitoring parameters (hemodynamics, neurological, respiratory). | Other | Adverse Event Group, No Adverse Event Group |
Primary outcome
Incidence of Adverse Events During Physical Therapy
Time frame: During the physical therapy session (from initiation up to immediate post-session evaluation, up to 1 hour per session).
Presence or absence of any adverse event (binary variable: Yes/No) occurring during or immediately following a physical therapy session in adult neurocritical ICU patients. Adverse events include: hypotension (drop in SBP > 20 mmHg), hypertension, tachycardia, bradycardia, oxygen desaturation, acute neurological deterioration, increase in intracranial pressure (ICP), or decrease in cerebral perfusion pressure (CPP) requiring therapy session suspension.
3 secondary outcomes
Clinical and Physiological Predictors of Adverse Events
Time frame: Baseline assessment immediately prior to each physical therapy session.
Frequency and Specific Types of Adverse Events
Time frame: During each physical therapy session throughout the ICU stay (retrospectively evaluated from October 2023 to April 2026).
Comparative Analysis of Hemodynamic versus Respiratory Variables
Time frame: Retrospective evaluation spanning the total ICU stay for each patient record (October 2023 to April 2026).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
Related trials for Critical Illness
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Recruiting
Development and Preliminary Validation of Intelligent Video Laryngoscope for Emergency Use
Critically Ill Patients Requiring Mechanical Ventilation
Active, not recruiting
Weighted Blankets for Agitation in Adults in the Intensive Care Unit
Psychomotor Agitation, Critical Illness
Not yet recruitingObservational study
Core Competencies in General Intensive Care Ultrasound (GenIUS): a Delphi Study
Critical Illness, Ultrasound
RecruitingObservational study
Predicting Extubation Failure Using Machine Learning
Extubation Failure, Critical Illness
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness and Brain Injury, run by Hospital H+ Queretaro at 2 sites in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events During Physical Therapy (time frame: During the physical therapy session (from initiation up to immediate post-session evaluation, up to 1 hour per session).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.